Raúl Lázaro Castro Almarales, MD
,
Allergens Department, National Center of Bioproducts (BIOCEN), Allergology and General Integral Medicine, La Habana, Cuba
Mercedes Ronquillo Díaz
,
Allergen Service, University Hospital "General Calixto García", Specialist Second Degree in Allergology, Cuba
Mirta Alvarez Castello, MD
,
Allergology Department, University Hospital, WAO Member, Cuban Society of Allergy , Asthma and Clinical Immunology, Member, Cuban Society of Immunology Member,, Havana, Cuba
Mayda González León, MD
,
Docent Polyclinic "Pedro Fonseca", Cuban Society of Integral General Medicine Member, Cuban Society of Allergy , Asthma and Clinical Immunology, Member, Cuban Society of Immunology Member,, Havana, Cuba
Alexis Labrada Rosado, PhD
,
WAO Member, Cuban Society of Immunology, Cuban Society of Allergy, Asthma and Clinical Immunology, Mayabeque, Cuba
José Severino Rodríguez Canosa, MD
,
Allergen Service, University Hospital "General Calixto García", WAO Member, Cuban Society of Immunology, Cuban Society of Allergy, Asthma and Clinical Immunology, Havana, Cuba
Maytee Mateo Morejón
,
Allergen, Biocen, Cuba
Yunia Oliva Diaz
,
Allergen Department, National Center of Bioproducts (BIOCEN), Cuban Society of Immunology, Cuban Society of Allergy, Asthma and Clinical Immunology, Mayabeque, Cuba
Bárbara Ivonne Navarro Viltres, MD
,
Docent Polyclinic "Federico Capdevila", WAO Member, Cuban Society of Allergy, Asthma and Clinical Immunology, Havana, Cuba
Background: World Health Organization position paper on immunotherapy recommends the using mite allergen vaccines for rhinitis and mild to moderate asthma. Allergic sensitization to domestic mites and particularly to
Dermatophagoides pteronyssinus,
Dermatophagoides siboney and
Blomia tropicalis has been described before in Cuba, as strongly linked to respiratory allergy symptoms. The aim of this work was to study the therapeutic effect and safety of allergen vaccines of these 3 mite species (VALERGEN, BIOCEN, Cuba) by subcutaneous route, in asthmatic patients.
Methods:
Three Double-Blind Placebo-Controlled clinical trials were performed in 40 patients each, showing asthmatic symptoms and positive predominant Skin Prick Test (SPT) to each mite, respectively. Half of patients received the active treatment consisting of subcutaneous injections with increasing doses, up to 6000 BU. Therapeutic effect was assessed after 6 and 12 months using symptoms/medication diary cards, peak expiratory flow (PEF) measures and skin sensitivity to investigated mites. Adverse reactions were classified using the World Allergy Organization scale.
Results: The total 1 year cumulative dose was 63035 BU, in an average of 20.5 injections. The treatment was effective in the reduction of clinical symptoms (up to 32%, 95%CI:28-36%; p=0.0006) and medication intake (23%, 95%CI:18-28%), as compared to control treatment. The skin sensitivity to the allergens decreased significantly (p=0.0001), with regard to the beginning of the treatment. The allergen amount needed to induce a positive SPT increased 297-fold. Improvement of the lung function was observed, expressed in a modest Peak-Expiratory-Flow increase (p<0.05) and reduction of PEF daily variability. SIT was considered effective in 71% of patients. The frequency of local adverse reactions was 2.4 % of injections.
Conclusions: Summing up subcutaneous immunotherapy, using VALERGEN vaccines, is effective and safe for the control and amelioration of the asthma.
